Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?
|ClinicalTrials.gov Identifier: NCT02800928|
Recruitment Status : Completed
First Posted : June 15, 2016
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Drug: CERC-501 Drug: Placebo||Phase 2|
The study will be performed in subjects who are heavy cigarette smokers currently not seeking treatment for tobacco use disorder.
The study is a crossover design study (within-subject analysis), which allows for subjects to be their own control.
Each period of the crossover consists of a 7-day out-patient treatment period followed by a single out-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Stress-Smoking Lapse Test. Upon completion, subjects will undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?|
|Actual Study Start Date :||June 30, 2016|
|Actual Primary Completion Date :||January 2, 2018|
|Actual Study Completion Date :||January 2, 2018|
Administered orally once daily, 10mg daily, 8 days
Placebo Comparator: Placebo
Administered orally daily, 8 days
- Latency [ Time Frame: 50 min ]Latency (in minutes and seconds) to time of first cigarette smoking during the delay period
- Number of Cigarettes Smoked [ Time Frame: 60 min ]Number of cigarettes smoked during the self administration period
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800928
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Sherry McKee, PhD||Yale University|